Ustekinumab and anti-Ustekinumab antibody-994

Test info

  
Ustekinumab and anti-Ustekinumab antibody
  
994
  
LAB994
  
MSO
  
Anti-interleukin antibody drug, Anti-IL12, IL23 inhibitor
Biologic monitoring, therapeutic drug monitoring (TDM)
DoseASSURE
Immunogenicity testing, an
  

Provides ustekinumab drug concentration and anti-ustekinumab antibodies in order to optimize treatment and facilitate clinical decision-making.

This assay may be helpful in any patients on ustekinumab therapy for Crohn's disease, psoriasis, or other autoimmune conditions.

Specimen

  
Serum
  
  
3.0 mL
  
1.0 mL
Submitting the minimum volume does not allow for repeat testing
  
  1. Allow a minimum clotting time of 30 to 60 minutes
  2. Spin

 

 

  

Serum separator (SST) tube

  
EDTA plasma
Heparin plasma
  

Red serum vial/tube - 5 mL

Dk green heparin (Li or Na), no gel

  

 

  
  1. Allow a minimum clotting time of 30 to 60 minutes for the serum tube
  2. Spin and separate
  
  

Ambient (preferred) - 14 days

Refrigerated - 14 days

Frozen - 14 days

Freeze/thaw cycles: Stable x 6

Performance

  
LabCorp Esoterix (504594): R-NX
  
1 day per week
  
11 - 25 days
  

Electrochemiluminescence immunoassay (ECLIA)

Clinical and Interpretive info

  

Ustekinumab: <0.1 μg/mL

  • Result ≥0.1 μg/mL indicates detection of ustekinumab
  • In the presence of anti-ustekinumab antibodies, the ustekinumab drug level reflects the free, antibody-unbound fraction of ustekinumab in serum.


Anti-ustekinumab antibody: <40 ng/mL

  • Result ≥40ng/mL indicates detection of anti-ustekinumab antibodies.

Billing

  
80299
82397

Tracking

  
11/14/2019
  
11/14/2019